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Some patients maintained outcomes for three years, and genetically modified CD4 T cells remain in circulation.

-convenient for patients by eliminating the need for multiple daily pills.

Jun 1 2007 (Vol. 27, No. 11)

http://www.genengnews.com/articles/chitem.aspx?aid=2119VRX496 suppressed viral loads and restored the immune system responses in chronic HIV patients. This is an important milestone in the development of what we believe could be the next generation of HIV therapy, says Riku Rautsola, Ph.D., president and CEO of VIRxSYS.

VRX496 is the first and only lentiviral vector therapy approved by the FDA for clinical trials. The backbone of VRX496 consists of a genetically engineered version of HIV in which all the infectious components are removed and replaced with the therapeutic payload a long antisense sequence that targets the HIV envelope protein and cripples the virus.

Preclinical studies show that HIV is unable to mutate around VRX496. which should prevent the formation of resistant strains. We have seen no resistance develop to our therapy in vivo or in vitro.

VRX496 is an autologous therapy that uses a patient’s own cells.

The goal is to repopulate a patient’s immune system with genetically engineered cells that promote immunity against HIV and prevent the progression to AIDS. Although not a cure, VRX496 could improve the quality of life for HIV patients by bringing viral loads down to low levels.

In a Phase I trial, five chronic HIV patients, who had failed to respond to multiple standard antiretroviral drug regimens, received one infusion of VRX496. All patients showed stable or decreased viral loads as well as stable or increased immune responses to HIV antigens. Four of the five had stable or increased CD4 T cells. Some patients have maintained these positive outcomes for up to three years, and the genetically modified CD4 T cells remain in circulation.

A Phase II study is under way in 40 chronic HIV patients to further establish the safety and tolerability of VRX496 and to determine the optimal dose.

Current anti-HIV drugs are small molecules that are highly toxic. Because HIV mutates rapidly, it often becomes resistant to conventional drug regimens taken by patients. VIRxSYS’ alternative gene therapy is designed to block all the mutation sites on HIV, preventing resistance. Thus VIRxSYS says that VRX496 overcomes the problems of toxicity and resistance.

VRX496, which is intended as a short-term therapy that offers long-term benefits, may be more convenient for patients by eliminating the need for multiple daily pills.

privately held VIRxSYS has a unique financing model. A group of private shareholders provides funds, and the company has not had to rely on traditional venture capital. “We are fortunate to have loyal shareholders who finance us,” Dr. Rautsola says.http://www.genengnews.com/articles/chitem.aspx?aid=2119 read the full article it is great...Jun 1 2007 (Vol. 27, No. 11)

I just noticed something from the Nov 06 press release of the results of phase I. This addreses a question that had been asked in another thread, I think the one about the rybozime (sp?) trial. On the latter trial there was a concern about cancer. I saw this in the Virxsys site:

VRX496 has been able to deliver genes permanently, reproducibly and efficiently to human cells without toxicity or serious adverse events, such as immunogenicity or insertional oncogenesis (cancer), that plagued earlier gene therapy trials.

Great news, and I guess it answers the question someone had raised of whether VRX496 could cause cancer! I do agree with Biz, I think this is an absolutely great "backup" treatment, should an outright cure not be hit upon in the next few years. Modified genes immune to HIV? I'll take them! J.

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"Hope is my philosophy Just needs days in which to beLove of Life means hope for meBorn on a New Day" - John David

When I talked to VIRxSYS a few weeks ago I was told something about the possiblity of the cells making "Memory Cells" That might be what keeps the VRX496 going and it may turn out that you have to get reVRX496ed every so often. I guess as the study progresses we will learn a lot more.

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If you are walking down the street and your pants drop to your ankles bend over pick them up and keep on walking!My Blog

I wanted to throw this in. The vector for VRX496 (Vector is what carries the VRX496 to the cell's DNA) can keep you from getting VRX496. In the study they test you for the antibody (Don't know what it is as it is a secret) if you have been exposed to the vector antibody you cannot get VRX496 because your body will kill off the vector and render the VRX496 Useless. I learned this Wednesday at my intake appointment.

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If you are walking down the street and your pants drop to your ankles bend over pick them up and keep on walking!My Blog

Hm, that's a bit of bad news I suppose. I thought this was going to be a universal treatment. However, the prevelence of the antibody, whatever it is, may be low in population, hopefully single digit percentages...guess more waiting for more info. Thanks for keeping us updated, we are all watching with cautious optimism! Best of luck. J.

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"Hope is my philosophy Just needs days in which to beLove of Life means hope for meBorn on a New Day" - John David